Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients—a study protocol for a randomised controlled trial (The RSVP Trial)

Rickard, Claire M., Marsh, Nicole M., Webster, Joan, Gavin, Nicole C., McGrail, Matthew R., Larsen, Emily, Corley, Amanda, Long, Debbie, Gowardman, John R., Murgo, Marghie, Fraser, John F., Chan, Raymond J., Wallis, Marianne C., Young, Jeanine, McMillan, David, Zhang, Li, Choudhury, Md Abu, Graves, Nicholas and Playford, E. Geoffrey (2015) Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients—a study protocol for a randomised controlled trial (The RSVP Trial). BMJ Open, 5 2: e007257.1-e007257.7. doi:10.1136/bmjopen-2014-007257


Author Rickard, Claire M.
Marsh, Nicole M.
Webster, Joan
Gavin, Nicole C.
McGrail, Matthew R.
Larsen, Emily
Corley, Amanda
Long, Debbie
Gowardman, John R.
Murgo, Marghie
Fraser, John F.
Chan, Raymond J.
Wallis, Marianne C.
Young, Jeanine
McMillan, David
Zhang, Li
Choudhury, Md Abu
Graves, Nicholas
Playford, E. Geoffrey
Title Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients—a study protocol for a randomised controlled trial (The RSVP Trial)
Journal name BMJ Open   Check publisher's open access policy
ISSN 2044-6055
Publication date 2015-02
Sub-type Article (original research)
DOI 10.1136/bmjopen-2014-007257
Open Access Status DOI
Volume 5
Issue 2
Start page e007257.1
End page e007257.7
Total pages 7
Place of publication London, United Kingdom
Publisher B M J Group
Collection year 2016
Formatted abstract
Introduction: Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3-4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload.

Methods and analysis: This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VADrelated bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, allcause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant.

Ethics and dissemination: Relevant ethical approvals have been received. CONSORT Statement recommendations will be used to guide preparation of any publication. Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care.
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes http://bmjopen.bmj.com/content/5/2/e007257.abstract?sid=af032cdf-fe6e-4c31-b00e-99f9a4613c65

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2016 Collection
School of Medicine Publications
School of Nursing, Midwifery and Social Work Publications
 
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Created: Wed, 18 Feb 2015, 09:11:44 EST by Vicki Percival on behalf of School of Nursing, Midwifery and Social Work